Invasive medical device cover with magnet

ABSTRACT

A cover for magnetizing a shaft of a tissue-penetrating medical device is disclosed including a sleeve member having a hollow body to form a protective closure over the shaft of the tissue-penetrating medical device. The open end of the hollow body provides a receiving space for receiving the shaft of the tissue-penetrating medical device. A magnet is disposed on the sleeve member. Medical devices and methods of magnetizing the shaft of a tissue-penetrating medical device using the cover are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/154,353, filed on May 13, 2016, now allowed and issued as U.S. Pat.No. 11,344,220 on May 31, 2022, the disclosure of which are incorporatedherein by reference in their entirety.

TECHNICAL FIELD

Aspects of the present disclosure relate to a cover for magnetizing atissue-penetrating medical device.

BACKGROUND

Traditionally, penetration of an invasive medical device such as aneedle and catheter tubing through skin tissue to reach the vein duringcatheter insertion is invisible to clinicians. For this reason,clinicians must rely on their first-hand experience with needleinsertion in combination with tactile sense to successfully identify thelocation of the vein. This may be a difficult task when attempting toaccess a small vein in a deep location under the skin, increasing riskof excess pain and/or injury to the patient. There are similar problemswith insertion of other invasive medical devices such as guidewires,catheters, introducer needles, stylets, scalpel and guidewire withrespect to the inability to precisely visualize the location of theinvasive medical device.

Emerging procedural guidance systems utilize a combination of ultrasoundand magnetic technologies to provide visualization of subdermal anatomyand device position in the in-plane and out-of-plane orientations. Thiscombination of ultrasound and magnetic methods also allows for theprojection or anticipation of the insertion device position relative tothe patient's anatomy, and thereby improves the likelihood ofsuccessfully accessing the vascular and completing the invasiveprocedure.

One leading technology targets the a portion of the device that isinserted into the patient, e.g., the needle cannula, as the portion ofthe invasive device for magnetization, while another leading technologyuses a permanent magnet located on the hub (e.g., needle hub) of thedevice. Current needle guidance systems typically utilize a magneticfield generated by magnetizing the needle by burying the needle into amagnetizer until the point of the needle hits a rubber stopping surface.FIG. 1 shows a perspective view of a currently available disposableneedle magnetizer 11. As shown in FIG. 1, current practice uses anunprotected needle 13 that is placed within the external disposableneedle magnetizer 11 to a depth defined by the bottom of the magnetizer.The current devices for magnetizing a needle prior to insertiongenerally are not sterile, not disposable, and not electronic.

In systems of the type shown in FIG. 1, damage to the needle can occurthat is not apparent to the user that can negatively affect theinsertion process. Also, the step of the user actively magnetizing themetal cannula has some limitations and inherent risks as this approachdoes not guarantee consistent magnetization since variability inclinician procedures such as depth of insertion, speed of process, andcentering of the needle in the magnetizer will result in differentdegrees of magnetization. Considering the potential inconsistency of auser fully inserting the needle to the bottom of the magnetizer 11, thesignificant risk of damaging the needle tip, and the increased potentialfor contamination during this step, it would be advantageous to have asystem that passively and consistently magnetizes the needle withoutintroducing the aforementioned additional risks, such as needle tipdamage and increased potential for contamination. Thus, there is a needfor a system that passively and consistently magnetizes invasive medicaldevices while reducing or eliminating risks, such as needle tip damageand needle contamination.

SUMMARY

A first aspect of the disclosure pertains to a cover for magnetizing atissue-penetrating medical device. A first embodiment pertains to acover comprising a sleeve member having a hollow body, the hollow bodyhaving a distal end and a proximal end to form a protective closure overa portion (e.g., a shaft) of a tissue-penetrating medical device. In oneor more embodiments, the sleeve member may have a length to cover theshaft of the tissue-penetrating medical device, and there are one ormore magnets disposed on the sleeve member. In one or more embodiments,the open end of the hollow tubular body provides a receiving space forreceiving at least a portion (e.g., the shaft) of the tissue-penetratingmedical device.

In one or more embodiments, the device-receiving space permits movementof the tissue-penetrating medical device into and out of thedevice-receiving space. In one or more embodiments, the device-receivingspace permits movement of the tissue-penetrating medical device in aparallel direction to the longitudinal axis of the tissue-penetratingmedical device.

In one or more embodiments, one or more magnets are provided on one sideof the device-receiving space. In one or more embodiments, two or moremagnets are provided, with the two magnets disposed around thedevice-receiving space. According to one or more embodiments, the two ormore magnets are disposed in slots positioned around the sleeve member.In one or more embodiments, the slots positioned around the sleevemember surround the device-receiving space.

In one or more embodiments, the cover may be sterile. In one or moreembodiments, the cover may be disposable. In one or more embodiments,the cover may be both sterile and disposable. In one or moreembodiments, the cover is plastic.

In one or more embodiments, the tissue-penetrating medical device may bea needle, cannula, stylet, catheter, scalpel or guidewire. According toone more embodiments, the cover passively magnetizes thetissue-penetrating medical device upon removal of the tissue-penetratingmedical device from the cover. In a specific embodiments, thetissue-penetrating medical device is a needle, which, when magnetized isadapted for use with a procedural guidance system which can locate andproject the position of the needle during an invasive medical procedure.

In one or more embodiments, the distal end of the tissue penetratingdevice includes a notch to provide immediate confirmation of vesselentry at a point of insertion.

A second aspect of the disclosure pertains to a medical device assemblywhich comprises a tissue-penetrating medical device, a cover formagnetizing the tissue-penetrating medical device including a sleevemember having a hollow body having a distal end and a proximal end toform a protective closure over at least a portion (e.g., a shaft) oftissue-penetrating medical device. In one or more embodiments, one ormore magnets may be disposed on the sleeve member. In one or moreembodiments, the sleeve member has a length to cover the shaft of thetissue-penetrating medical device, for example, a needle cannula. In oneor more embodiments, the open end of the hollow tubular body provides areceiving space for receiving at least part of the tissue-penetratingmedical device. In one or more embodiments, the tissue-penetratingmedical device includes a needle assembly including a needle and theshaft, and when the shaft is magnetized, the tissue-penetrating medicaldevice is configured for use in a procedural guidance system to locateand project a position of the shaft during an invasive medicalprocedure. In one or more embodiments, the medical device assemblyfurther comprises a catheter having a proximal end and a distal end; acatheter adapter having a distal end, a proximal end, an overall lengthextending from the distal end to the proximal end, an internal cavity,an upper portion, a lower portion and a tip region having a distalopening having a circumference through which the catheter extends, thecatheter adapter being connected to the proximal end of the catheter;and the shaft having a proximal end and a distal end, and the needleassembly includes a needle hub connected to the proximal end of theshaft, the needle hub including a hub magnet. In one or moreembodiments, the catheter adapter is connected to the proximal end ofthe shaft.

A third aspect of the disclosure pertains to a method of magnetizing atissue-penetrating medical device. The method includes positioning atleast a shaft of the tissue-penetrating medical device in a coverincluding a receiving space, the cover including a magnet on the cover;and removing the tissue-penetrating medical device from the receivingspace to magnetize the shaft of the tissue-penetrating medical device insaid receiving space. The tissue-penetrating medical device is a needle,cannula, stylet, catheter, scalpel or guidewire. In one or moreembodiments, the magnet is a collar surrounding the cover.Alternatively, the cover includes at least two magnets.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a prior art disposable needlemagnetizer;

FIG. 2 shows a perspective view of an embodiment of a needle cover ofthe present disclosure;

FIG. 3A shows an embodiment of a tissue-penetrating medical device priorto insertion into a needle cover of the present disclosure;

FIG. 3B shows an embodiment of a tissue-penetrating medical devicepartially inserted into a needle cover of the present disclosure;

FIG. 3C shows an embodiment of a tissue-penetrating medical device fullyinserted into a needle cover of the present disclosure;

FIG. 4 shows an embodiment of a tissue-penetrating medical device fullymagnetized after being removed from a needle cover of the presentdisclosure;

FIG. 5 shows an embodiment of a tissue-penetrating medical device with amagnetic collar;

FIG. 6A shows a partial perspective view of a tip of a needle cover withan embedded magnet;

FIG. 6B shows an end view of a needle cover with one embedded magnet;

FIG. 6C shows an end view of a needle cover with two embedded magnets;and

FIG. 7 shows an embodiment of a medical device.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the disclosure, it isto be understood that the description provided is not limited to thedetails of construction or process steps set forth in the followingdescription. The devices and methods described herein are capable ofother embodiments and of being practiced or being carried out in variousways.

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.

Aspects of the disclosure pertain to an improved system that addressesthe challenges to the existing technology and systems to passivelymagnetize a needle, such as a needle used with a peripheral intravenous(IV) catheter. One or more embodiments of the present disclosure relateto a tissue-penetrating medical device with a needle cover with anintegrated magnet on or within the needle cover. According to one ormore embodiments, the device and system of the present disclosurepassively and consistently magnetizes the needle. In one or moreembodiments, passive magnetization of an invasive medical device isachieved with no additional or new clinical steps because the invasivemedical device already includes a cover that covers the distal tip ofthe device. In one or more embodiments, the devices and systemsdescribed herein provide more precise control of the location of themagnet relative to the device to be magnetized, resulting in a moreconsist and predictable magnetic field applied to the invasive medicaldevice. In one or more embodiments, the devices and methods describedherein create no additional risk of needle damage compared to existingmagnetizer devices and no additional risk for contamination compared toexisting magnetizer devices.

Referring now to FIG. 2, showing one aspect of the disclosure pertainsto a cover 12 for magnetizing a tissue-penetrating medical device 10comprising a sleeve member 14 having a hollow body 20 having a distalend 21 and a proximal end 22 to form a protective closure over the shaft34 of a tissue-penetrating medical device 30. In one or moreembodiments, the hollow body 20 can be tubular or any other suitableshape. In the embodiment shown, the tissue-penetrating medical device 30is shown as a needle assembly including a needle housing 32 and a shaft34 of the needle having a sharp distal tip 36. It will be appreciatedthat in FIG. 2, the sleeve member 14 is shown as transparent and theshaft 34 of the tissue-penetrating medical device 30 is visible. Thesleeve member 14 has a length L that covers the shaft 34 of thetissue-penetrating medical device 30, including the sharp distal tip 36to prevent accidental needle sticks. The arrows shown in FIG. 2 withrespect to the length “L” also show the longitudinal axis of the shaft34. The open end 22 of the hollow body 20 provides a device-receivingspace 40 for receiving at least the shaft 34 of the tissue-penetratingmedical device 30. The cover 12 includes at least one magnet 50, and inthe embodiment show, at least two magnets 50 disposed on the sleevemember 14.

The device-receiving space 40 is sized and shaped to permit movement ofthe shaft 34 of the tissue-penetrating medical device 30 into and out ofthe device-receiving space 40. In one embodiment, the device-receivingspace 40 permits movement of the shaft 34 of the tissue-penetratingmedical device 30 into the device-receiving space 40 in a movement thatis parallel to the longitudinal axis of the shaft 34 oftissue-penetrating medical device 30. The cover 12 passively magnetizesthe shaft 34 of the tissue-penetrating medical device 30 when the cover12 is removed from the shaft 34 of the tissue-penetrating medicaldevice.

FIGS. 3A to 3C show a medical device 100 including a tissue-penetratingmedical device 130, a cover 112 for magnetizing the shaft 134 of thetissue-penetrating medical device 130. The cover 112 includes a sleevemember 114 having a hollow tubular body 120 having a distal end 121 anda proximal end 122 to form a protective closure over the shaft 134 ofthe tissue-penetrating medical device 130, the sleeve member 114 havinga length L to cover the shaft 134 of the tissue-penetrating medicaldevice 130, the shaft 134 having a length L2 and a distal tip 136. Theopen end 122 of the hollow tubular body 120 provides a receiving space140 for receiving at least the shaft 134 of the tissue-penetratingmedical device 130, and two magnets 150 on the sleeve member 134. Itwill be understood that while two magnets 150 are shown, the device isnot limited to a particular number of magnets or to a particularlocation of the magnets around the sleeve member. Magnets 150 may bepositioned in any position or orientation around the sleeve member. Inone or more embodiments, a single magnet can be utilized to magnetizethe shaft 134, or more than two magnets can be utilized.

In embodiments in which two magnets are utilized, the orientation of themagnetic fields of the two magnets can vary. One magnet can have northand south poles on axis with shaft of the tissue-penetrating medicaldevice, while the second magnet can have north and south poles off-axisor perpendicular to the shaft of the tissue-penetrating medical device.Alternatively, the two magnets both can have north and south poles offaxis with the shaft of the tissue-penetrating medical device, or the twomagnets both can have north and south poles on axis with the shaft ofthe tissue-penetrating medical device.

FIG. 3A shows the tissue-penetrating medical device 130 prior toinsertion into the cover 112 of the present disclosure. The tissuepenetrating medical device 130 includes the shaft 134 having a lengthL2, a distal tip 136, and the shaft 134 is mounted to the housing 130 bya hub 152. In one or more embodiments, the hub 152 includes a hub magnet155. In one or more embodiments, hub magnet 155 is a permanent fixedmagnet. Hub magnet 155 may provide for a fixed magnetic reference pointwhen the tissue-penetrating needle is used with a combination ofultrasound and magnetic technologies to provide visualization ofsubdermal anatomy and device position. FIG. 3B shows the shaft 134 ofthe tissue-penetrating medical device 130 partially inserted into acover 112 of the present disclosure. FIG. 3C shows the shaft 134 of thetissue-penetrating medical 30 device fully inserted into a cover 112 ofthe present disclosure. The medical device 100 as shown in FIG. 3C canbe packaged and ready for use for a medical procedure. The medicaldevice 100 shown in FIG. 3C can be packaged together with other devicesas part of a larger medical device assembly. Thus, FIG. 3C shows amedical device 100 which is a needle subassembly having a cover 112having at least one magnet 150 configured to magnetize shaft 134 of themedical device 100 upon removal of the cover 112 from the shaft. Themedical device 100 could further be packaged as part of a catheterassembly including a catheter adapter subassembly.

FIG. 4 shows the tissue-penetrating medical device 130 with the shaft134 magnetized after the shaft 134 has been removed from the needlecover shown in FIGS. 3B-3C. As shown in FIGS. 3B-3C, two magnets 150 canbe integrated into cover 112 so that the cover 112 passively magnetizesthe shaft 134 upon removal of cover 112. The embodiment shown in FIGS.3B-3C shows two magnets 150 positioned around cover 112. Such a covercould be easily integrated in existing catheter assemblies and otherinvasive medical devices such as guidewires and stylets to enable themagnetization of the shafts of various invasive medical devices uponremoval of the cover to passively magnetize the shaft. The axialposition of the magnets can be modified and positioned relative to theshaft length and the desired portion of the shaft to be magnetized. Forexample, in the case of a needle, the magnets can be specificallypositioned based on the gauge and length of the needle. As shown in FIG.3B, the positioning of the magnets would result in the shaft 134 beingmagnetized from the approximately the position P shown in FIG. 3 to thedistal tip 136 of the shaft 134 as the portion of the shaft from P tothe distal tip P will be will be moved through the magnetic fieldprovided by the magnets 150. This the tissue-penetrating medical device130 can now be used with a procedural guidance system that utilizemagnetic sensors as a means of measuring and predicting needle tiplocation relative to the target anatomy. In one or more embodiments, thedistal end of the tissue penetrating medical device 130 includes a notch137 located on the distal tip 136 of the shaft 134 to provide immediateconfirmation of vessel entry at a point of insertion.

FIG. 5 shows an embodiment of a tissue-penetrating medical device 230including a cover 212 having a magnetizing collar 260, which can be amagnet in the shape of the collar 260 as shown. The cover 212 includes asleeve member 214 having a hollow tubular body 220 having a distal end221 and a proximal end 222 to form a protective closure over the shaft234 of the tissue-penetrating medical device 230. The open end 222 ofthe hollow tubular body 220 provides a receiving space 240 for receivingat least the shaft 234 of the tissue-penetrating medical device 230. Themagnetizing collar 260 is show as being disconnected from the cover 212,but the magnetizing collar 260 is variably positioned along the lengthL3 of the cover 212 relative to the shaft 234. The magnetizing collar260 can be used as a single use disposable item, or the magnetizingcollar 260 may be reusable since the needle cover stays in place duringthe magnetization step. Therefore, according to one or more embodiments,the magnetizing collar 260 is detachably mounted to the cover 212. Inalterative embodiments, the magnetizing collar 260 is permanentlymounted to the cover 260. The magnetizing collar 260 can be slidablymoved along the length of the cover 212. In other embodiments, thelength L4 of the magnetizing collar 260 may be equal to the length L3 ofthe cover 212 such that the entire shaft 234 of the tissue-penetratingmedical device 230. In other embodiments, the length L4 of themagnetizing collar 260 is 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% or 90%of the length L3 of the cover 212. The magnetizing collar 260 can be atubular magnet that substantially surrounds the periphery of the cover,or the magnetizing collar 260 can be a cover made of plastic or othermaterial with an array of magnets substantially surrounding theperiphery of the cover.

FIGS. 6A-6C show one way of integrating at least one magnet with a coverfor a tissue-penetrating medical device. FIG. 6A shows a partialperspective view and FIG. 6B shows an end view of a cover 312 having anembedded magnetic 350 in the wall 360 of the cover 360. The magnet 350is embedded in a slot 362. The magnet 350 can be sized to be slidablymounted within the slot 362 and held in place by friction fit, or themagnet can be attached with an adhesive or other suitable ways.Alternatively, the magnet 350 could be integrally molded into the wall360 during the forming process for the cover 312. The length L5 of themagnet 350 shown in FIG. 6A is shown as being less than the length ofthe cover. According to one or more embodiments, the length L5 of themagnet 350 can be equal to the length of the cover, or 10%, 20%, 30%,40%, 50%, 60%, 70%, 80% or 90% of the length of the cover.

FIG. 6C shows an embodiment of a cover 412 with a first magnet 450 in afirst slot 462 of the wall 460 of the cover 412, and a second magnet 452in a second slot 464 in the wall 460 of the cover. The first magnet 450and second magnet 452 are shown as being positioned around the cover412, for example, 180 degrees from each other. It will be understoodthat the two magnets can be in other positions with respect to eachother. Additionally, the cover 412 can include more than two magnets.The first magnet 450 and second magnet 452 can be slidably mounted inthe respective first slot 462 and the second slot 464 and held in placeby friction fit, or they could be held in place by adhesive. Inalternative embodiments, the magnets can be integrally molded with thecover 412. The two or more magnets may have oppositely oriented poles.

In alternative embodiments, a needle cover is provided that hasgeometric dimensions that permit the needle cover to be placed insideexisting needle magnetizing devices while the needle cover is coveringthe shaft of the needle. The distal end of the needle cover may be usedto limit the depth of insertion by providing a stop to contact thebottom of the needle magnetizing device. Alternatively, a feature nearthe proximal portion of the needle cover can be provided on the cover tolimit the depth of insertion by a stop on the proximal opening of theneedle magnetizer.

The covers described herein can have a variety of properties. In one ormore embodiments, the covers are formed from plastic. In one or moreembodiments, the covers are sterile. In one or more embodiments, thecovers are disposable. In other embodiments, the covers may be bothsterile and disposable.

The tissue-penetrating medical device may be a needle, catheter,introducer needle, stylet, scalpel or guidewire. In one embodiment, thetissue-penetrating medical device is a needle, which when magnetized canbe used with a procedural guidance system to locate and project theposition of the needle during an invasive medical procedure. Thetissue-penetrating medical device according to one or more embodimentsis includes a magnetizable metallic material. In a specific embodiment,the magnetizable metallic material is magnetizable stainless steel.

The covers described herein may also be incorporated into a vascularaccess device comprising a catheter, a catheter adapter subassembly, anda needle subassembly including an introducer needle, a needle hubconnected to the proximal end of the introducer needle and a needlecover according to any of the embodiments described herein. The needlecover may include a plastic sleeve member having a hollow tubular bodyto form a protective closure over the introducer needle, and two or moremagnets disposed on the needle cover as described herein.

An example of a medical device assembly, specifically a vascular accessdevice including a catheter according to any of the foregoingembodiments described above is illustrated in FIG. 7. The medical deviceassembly 500 shown in FIG. 7 comprises a tissue penetrating medicaldevice in the form of a needle subassembly 514, and a catheter adaptersubassembly 512 including a catheter adapter body 516 and a cathetertubing 518 and a permanent magnet element 532. In one or moreembodiments, the catheter adapter is connected to the proximal end ofthe shaft.

Permanent magnet element 532 may serve as an additional reference pointwhen used in combination with ultrasound and magnetic technologies toprovide visualization of subdermal anatomy and device position. A needle(not shown) within the catheter tubing 518 shows a magnetic portion 530,and the needle has been magnetized upon removal of a cap including amagnet as described with respect to FIGS. 2-7 herein. Magnetizing theneedle with the cover as described herein creates a magnetic field 515in the magnetic region 530.

The medical device 500 may be a vascular access device which includes alateral access port 556 and may be connected to a section of anextension tube 560 for establishing fluid communication between an IVfluid source and the catheter tubing 518. In one or more embodiments,the extension tube 560 is built-in to reduce contamination andmechanical phlebitis by eliminating manipulation at the insertion site.In one or more embodiments, the extension tube 560 is compatible withhigh pressure injection. In one or more embodiments, the extension tube560 provides continuous confirmation of vessel access during advancementof the catheter into the patient vein.

In one or more embodiments, a needle of a needle subassembly 514 isinserted into a lumen of the catheter tubing 518. The needle subassembly514 is shown as including finger grips 584 positioned at the sides ofthe needle subassembly 514 to facilitate various insertion techniques.In one or more embodiments, bumps may be present on the finger grip toindicate where to the user may grip the device for needle removal. Inone or more embodiments, a thumb pad 585, having a gently convexsurface, is provided at the proximal end of the needle subassembly 514.A flange 586, having a gently convex surface, is provided at theproximal end of the needle subassembly 514 to provide a finger pad. Awing member 570, thumb pad 585 and flange 586 may be utilized by theuser during insertion, permitting the user to elect which insertiontechnique to employ.

In one or more embodiments, the needle subassembly 514 includes a needleshield 580. The needle shield 580 may be a design adapted to secure thetip of the needle within the shield after use. In one or moreembodiments, the needle shield 580 may be activated passively. Theneedle tip is completely covered by the needle shield 580 in a fixedposition. In one or more embodiments, a ferrule, crimp or otherstructure may be included near the tip for engagement with a needleshield in certain applications.

A push tab 581 may be provided to facilitate catheter advancement duringinsertion. The push tab 581 also allows for one-handed or two-handedadvancement. In one or more embodiments, the push tab 581 is removedwith the needle shield 580. A clamp 582 may also be included on theextension tubing to prevent blood flow when replacing the access port.

In one or more embodiments, the vascular access device 500 furtherincludes a first luer access 572 and a second luer access 573 in fluidcommunication with the extension tube 560, a blood control split septum574 associated with the first luer access 572, and an air vent 576associated with the second luer access 573. Split septum 574 allows fora reduction in catheter-related bloodstream infection (CRBSI) whileproviding unrestricted flow and a straight fluid path and functions as ablood control septum. In one or more embodiments, the split septum 574may be located in an internal cavity of the catheter adapter or on thedistal end of the catheter adapter. In yet another embodiment, the splitseptum 574 may be located on a distal end of the extension tube 560. Theair vent 576 allows air to escape from the system during insertion,providing continuous confirmation of vascular access while preventingleakage of blood from the system during insertion. In one or moreembodiments, the air vent 576 may be at the distal end of extension tube560.

In one or more embodiments, the base unit can be integrated into theultrasound system with the ultrasound processor and a magnetometricdetector being in direct communication with the ultrasound system eithervia wireless link or using the same physical cable.

Another aspect of the disclosure pertains to a method of magnetizing atissue-penetrating medical device. Embodiments of the method includepositioning a shaft of the tissue-penetrating medical device in a coverincluding a device-receiving space, the cover including at least onemagnet on the cover; removing the tissue-penetrating medical device fromthe device-receiving space to magnetize the shaft of thetissue-penetrating medical device.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe disclosure. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the disclosure.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the disclosure herein has provided a description with referenceto particular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent disclosure. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present disclosure without departing from the spiritand scope of the disclosure. Thus, it is intended that the presentdisclosure include modifications and variations that are within thescope of the appended claims and their equivalents.

What is claimed is:
 1. A medical device assembly comprising: atissue-penetrating medical device including a shaft; and a removablecover for magnetizing the shaft of the tissue-penetrating medicaldevice, the removable cover including a sleeve member comprising ahollow tubular body to form a protective closure over the shaft of thetissue-penetrating medical device prior to use, the sleeve membercomprising a length that covers the shaft, an open end of the hollowbody providing a receiving space for receiving at least the shaft of thetissue-penetrating medical device; and, a magnetizing collar detachablefrom the cover and slidably movable along a length of the coverproviding control of the location of the magnetizing collar relative tothe medical device.
 2. The medical device assembly of claim 1, whereinthe tissue-penetrating medical device is a needle assembly, a stylet,catheter, introducer needle, scalpel or guidewire.
 3. The medical deviceassembly of claim 1, wherein the tissue-penetrating medical deviceincludes a needle assembly and the collar is effective to magnetize theshaft upon removal of the shaft of the tissue-penetrating medical devicefrom the cover.
 4. The medical device assembly of claim 3, wherein thetissue-penetrating medical device includes a needle assembly including aneedle and the shaft, and when the shaft is magnetized, thetissue-penetrating medical device is configured for use in a proceduralguidance system to locate and project a position of the shaft during aninvasive medical procedure.
 5. The medical device assembly of claim 4,further comprising: a catheter having a proximal end and a distal end; acatheter adapter having a distal end, a proximal end, an overall lengthextending from the distal end to the proximal end, an internal cavity,an upper portion, a lower portion and a tip region having a distalopening having a circumference through which the catheter extends, thecatheter adapter being connected to the proximal end of the catheter;and the shaft having a proximal end and a distal end, and the needleassembly includes a needle hub connected to the proximal end of theshaft, the needle hub having one or more magnets thereon.
 6. The medicaldevice assembly claim 5, wherein the one or more magnets comprises afixed permanent magnet.
 7. The device of claim 5, wherein a distalportion of the shaft of the tissue-penetrating medical device includes anotch to provide immediate confirmation of vessel entry at a point ofinsertion.
 8. A method of magnetizing the medical device assembly ofclaim 1 comprising: positioning at least a shaft of thetissue-penetrating medical device in the magnetizing collar; andremoving the tissue-penetrating medical device from the magnetizingcollar to magnetize the shaft of the tissue-penetrating medical devicein said receiving space.
 9. The method of claim 8, wherein thetissue-penetrating medical device is a needle, cannula, stylet,catheter, scalpel or guidewire.
 10. The method of claim 8, wherein themagnetizing collar surrounds the cover.